(44 days)
Not Found
No
The document describes a device that delivers radio frequency heat and does not mention any AI or ML components.
Yes
The device is intended to treat various medical conditions, including benign and malignant dermatological indications, by destroying diseased tissue using radio frequency heat, which is a therapeutic action.
No
The device description states it "delivers precisely controlled localized current field radio frequency heat to selectively destroy certain diseased tissue," indicating a therapeutic function rather than a diagnostic one.
No
The device description explicitly states it is a "battery-operated device that delivers precisely controlled localized current field radio frequency heat," indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is intended to treat various dermatological conditions and basal cell carcinoma. IVD devices are used to diagnose or aid in the diagnosis of diseases or conditions by examining specimens taken from the human body (like blood, urine, tissue).
- Device Description: The device description explains that it delivers radio frequency heat to destroy diseased tissue. This is a therapeutic action, not a diagnostic one.
- Lack of Diagnostic Function: There is no mention of the device analyzing biological samples or providing diagnostic information.
The device described is a therapeutic device used for the treatment of specific medical conditions.
N/A
Intended Use / Indications for Use
The device is intended to treat benign superficial dermatological indications that includes; warts, molluscum contagiosm, angioma, fibroma, seborrheic keratoses, acrochordon, syringoma, hydrocystoma, calvus, actinic keratoses, keloids, epidermoid cysts, cystic acne, cutaneous leishmaniasis, atypical mycobacteria, and dermatophytosis. In addition, it is intended to treat basal cell carcinoma.
Product codes (comma separated list FDA assigned to the subject device)
GEI
Device Description
The ThermoMed Model 1.8 is a battery-operated device that delivers precisely controlled localized current field radio frequency heat to selectively destroy certain diseased tissue.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A single center study of 60 patients was conducted to evaluate the safety and efficacy of the ThermoMed™ Model 1.8 device in the treatment of basal cell carcinoma. Eighty five (85) percent of patients showed no evidence of tumor cells upon histological examination 3 months after a single treatment with the ThermoMed™ device. Treatment related side effects were low, with two reports of mild infection at the treatment site, one report of pain after treatment, and one report of light headedness. Patient satisfaction was high, with average patient ratings as follows: treatment comfort at 8.35, treatment convenience at 8.97, and side effects at 9.02, on a 1-10 scale with 10 being most favorable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K021117, K894166, K970493, K800617
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
0
Image /page/0/Picture/0 description: The image shows the logo for Thermosurgery Technologies, Inc. The logo consists of a stylized wave-like graphic on the left, followed by the company name in a bold, sans-serif font. The word "THERMOSURGERY" is on the top line, and "TECHNOLOGIES, INC." is on the bottom line.
Thermosurgery Technologies Inc. ThermoMed Model 1.8 510(k) Submission Traditional
| 5. 510(k) Summary | K063748 | Page 1 of 2 |
|---|---|---|
| Submission Date | December 7, 2006 | FEB - 1 2007 |
| Submitter's Name | ||
| and Address | Thermosurgery Technologies Inc. | |
| 2901 W. Indian School Rd | ||
| Phoenix, AZ 82017 | ||
| Contact Person | Gene R. Hedin | |
| Phone: 602-264-7300 | ||
| Fax: 602-248-3809 | ||
| Email: generhedin@thermosurgery.com | ||
| Name of Medical | ||
| Device | Trade Name: ThermoMed Model 1.8 | |
| Common Name: localized current field radio frequency | ||
| instrument | ||
| Classification Name: Device, Electrosurgical, Cutting and | ||
| Coagulation Accessories, Class II | ||
| Product Code: GEI / 878.4000/Class II | ||
| Substantial | ||
| Equivalence | ThermoMed Model 1.8 (K021117) | |
| Thermosurgery (K894166) | ||
| ConMed Hyfrecator 2000 (K970493) | ||
| Birtcher (K800617) | ||
| Device | ||
| Classification | Class II | |
| Device Description | The ThermoMed Model 1.8 is a battery-operated device | |
| that delivers precisely controlled localized current field radio | ||
| frequency heat to selectively destroy certain diseased | ||
| tissue. | ||
| Indications for Use | The device is intended to treat benign superficial | |
| dermatological indications that includes; warts, molluscum | ||
| contagiosm, angioma, fibroma, seborrheic keratoses, | ||
| acrochordon, syringoma, hydrocystoma, calvus, actinic | ||
| keratoses, keloids, epidermoid cysts, cystic acne, | ||
| cutaneous leishmaniasis, atypical mycobacteria, and | ||
| dermatophytosis. In addition, it is intended to treat basal | ||
| cell carcinoma. | ||
| Summary | ||
| predicate device | ||
| SE | The ThermoMed Model 1.8 for this submission is the same | |
| instrument as the ThermoMed 1.8 (K02117) currently | ||
| cleared for marketing in the United States and substantially | ||
| equivalent to the Thermosurgery (K894166), ConMed | ||
| (K970493) and the Bircher (K800617). This submission if | ||
| for indications statement changes. A summary of the | ||
| clinical trial performed under IDE G020145 has been | ||
| included in this submission. | ||
| Safety | The device is the same as the predicate device (K02117). | |
| Clinical trial performed under IDE G020145 submitted data | ||
| shows safety and effectiveness of the device. | ||
| Clinical trial | ||
| summary | A single center study of 60 patients was conducted to | |
| evaluate the safety and efficacy of the ThermoMed™ Model | ||
| 1.8 device in the treatment of basal cell carcinoma. Eighty | ||
| five (85) percent of patients showed no evidence of tumor | ||
| cells upon histological examination 3 months after a single | ||
| treatment with the ThermoMed™ device. Treatment related | ||
| side effects were low, with two reports of mild infection at | ||
| the treatment site, one report of pain after treatment, and | ||
| one report of light headedness. Patient satisfaction was | ||
| high, with average patient ratings as follows: treatment | ||
| comfort at 8.35, treatment convenience at 8.97, and side | ||
| effects at 9.02, on a 1-10 scale with 10 being most | ||
| favorable. |
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Thermosurgery Technologies Inc. ThermoMed Model 1.8 510(k) Submission Traditional
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and the comments of the comments of
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The background is white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Thermosurgery Technologies, Inc. % Mr. Gene R. Hedin CEO 2901 W. Indian School Road Phoenix, Arizona 85017
FEB - 1 2007
Re: K063748 Trade/Device Name: ThermoMed Model 1.8 Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 7, 2006 Received: December 19, 2006
Dear Mr. Hedin:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 – Mr. Gene R. Hedin
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely ye
Ka Dio Pm
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Thermosurgery Technologies Inc. ThermoMed Model 1.8 510(k) Submission Traditional
KO63748
- Indications for Use Statement
Indications for Use
510 (k) Number:
Device Name:
ThermoMed Model 1.8
Indications for Use:
The device is intended to treat benign superficial dermatological indications that includes; warts, molluscum contagiosm, angioma, seborrheic keratoses, acrochordon, syringoma, hydrocystoma, calvus, actinic keratoses, keloids, epidermoid cysts, cystic acne, cutaneous leishmaniasis, atypical mycobacteria, and dermatophytosis. In addition, it is intended to treat basal cell carcinoma.
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-the-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Olohe
(Division Sign-Off Division of General, Restorative, and Neurological Devices
5100 Number 11063748 Page 1 of 1
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